AccessGUDID - DEVICE: CALMING HEAT (06936189900869)

GUDID

Device Identifier (DI) Information

Brand Name: CALMING HEAT
Version or Model: CHNSCC3-3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CWT82004
Company Name: GUANGDONG OKAY TECHNOLOGY CO.,LTD.

Primary DI Number: 06936189900869
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 548239775 *Terms of Use

Device Description: Input DC 5V, 1A, Power 5W. CALMING HEAT Copper Charcoal Neck Wrap N&I 3 Heat ,3 Vibration, This device complies with part 15 of FCC rules.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dfd30d8c-8319-4b9a-8da9-fec9c90d68ea
Public Version Date: July 22, 2024
Public Version Number: 2
DI Record Publish Date: June 16, 2024